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WO1996002214A1 - Catheter urinaire - Google Patents

Catheter urinaire Download PDF

Info

Publication number
WO1996002214A1
WO1996002214A1 PCT/AU1995/000429 AU9500429W WO9602214A1 WO 1996002214 A1 WO1996002214 A1 WO 1996002214A1 AU 9500429 W AU9500429 W AU 9500429W WO 9602214 A1 WO9602214 A1 WO 9602214A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
pressure
urethral
catheter according
intra
Prior art date
Application number
PCT/AU1995/000429
Other languages
English (en)
Inventor
Penelope Jane Sullivan
Original Assignee
Penelope Jane Sullivan
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Penelope Jane Sullivan filed Critical Penelope Jane Sullivan
Priority to AU29180/95A priority Critical patent/AU2918095A/en
Publication of WO1996002214A1 publication Critical patent/WO1996002214A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

  • This invention relates to a catheter for controlled micturition in subjects suffering from urinary incontinence or related urinary disorders.
  • Urinary incontinence and retention represent a much under-diagnosed loss of voluntary control over micturition.
  • Recent studies reveal that an estimated 30% of adults over the age of 65 years suffer from incontinence, compared with 5 - 15% of the younger 20 to 60 year old age group. The incidence is highest in nursing home patients (50%). Whilst acute retention is an urgent condition requiring immediate relief, medical or surgical, incontinence is usually a chronic distressing and socially embarrassing disorder suffered in silence and often unresponsive to surgical intervention. Indeed, for many sick or elderly patients, their general debilitation precludes surgery. Retention is due to increased resistance to urine- outflow.
  • Tiis may be due to reversible factors su i as adverse medication side-effects, infection, pain or faecal impaction. MOre serious causes include tumours, scarring, fibrosis and oedema. Incontinence results from inadequate resistance to urine-outflow and may be total (absolute incontinence) or partial (stress incontinence) as with coughing, laughing or exercise.
  • Causes of incontinence include: weakness and descent of the pelvic floor muscles, with loss of the normal bladder-neck angle, and atrophy of the perl-urethra1 striated muscle fibres (eg after childbirth) ; destruction or distortion of the urethral sphincter due to surgery (eg post-prostatectomy, or following pelvic floor or bladder surgery); detrusor muscle instability;
  • atrophic-vaginitis related loss of tone in the periurethral tissues (post enopausal decline in oestrogen levels ) ; neurogenic causes (post cerebrovascular accident, spinal cord pathology and diseases such as multiple sclerosis, Parkinson's disease and dementia); and medication-induced.
  • Non-surgical attempts to deal with the problem fall into the following broad categories.
  • this invention provides a urethral catheter comprising flexible tubing having an end and an external urethral meatal end, and 2 pressure sensitive valves disposed between said lntra-veslcular end and said external urethral meatal 4 end, wherein said tubing at said intra- esicular end has shape memory properties proximal to the region of the internal urethral meatus which provides a bend or curve in said catheter for retention thereof in the bladder.
  • the intra-vesicular end of the catheter preferably extends well into the bladder lumen and can include a plurality of openings in the tubing. The plurality of openings aids passage of urine into the catheter.
  • the entire intra- esicular portion can have shape memory properties.
  • the portion having shape memory properties adopts a helical or spiral shape.
  • a preferred shape is a spiral shape with the broadest part of the spiral resting against the bladder wall when the catheter is in situ.
  • the pressure-sensi ive valves are typically pciiritioned in the intra-vesicular portion of the catheter.
  • the valve is positioned proximal to the internal urethral meatus when the catheter is in situ.
  • the valves may equally advantageously be positioned in the urethral section of the catheter. When plurality of openings are present in the intra-vesicular portion of the catheter the openings can extend to just before the valve.
  • the pressure-sensiti e valve can be any in- line valve which opens at a pressure of 30 to 50cm H20.
  • a preferred range for opening of the valve in females is 0 to 50cms H20 while the preferred range for males is 30 to 40cm H20.
  • the valve is advantageously similar to pressure- sensitive valves used as neurosurgica1 shunts and is preferably unidirectional.
  • a second pressure-sensitive valve - a ball and spring arrangement - is located within either the terminal intra-vesicular or urethral portions of the catheter. This ball and spring valve features a spring firmly attached at its base to the internal surface of the walls of the catheter tubing.
  • the spring is designed to compress at pressures equal to or greater than 60 to 70 cms water pressure.
  • This valve is not activated by the lower 30 to 50 cms water pressure of the normal emptying bladder.
  • the ball and spring valve is designed to withstand the sudden rises in intra-abdominal and intra-vesicular pressure caused by coughing, sneezing, exercise etc., thus preventing stress incontinence.
  • the external urethral meatal er.d of the catheter advantageously includes an external member such as a ring or bevel.
  • the external member facilitates removal of the catheter via gentle traction.
  • the catheter in situ ends flush with the external urethral meatus.
  • the proximal section of the urethral catheter features an external soft distensible collar with perforations on the aspect of the collar adjacent to the internal urethral meatus. Any leakage of urine around the catheter at the internal urethral meatus will enter these openings in the collar, gradually filling the distensible collar, so as to occlude any space around the catheter.Such leakage of urine is typically due to inexact fit of the catheter or gradual atrophy of the urethral tissues, as with any long-term catheter usage. Upon removal of the catheter, the collar-contents - typically only a few millilitres of urine - will be expelled back into the bladder, that urine then draining during the catheter change, or via the next I . D t.
  • Catheters according to the invention are provided in graduated gauges with the gauge being compatible with the transverse dimensions of the pressure -sensitive valves. Catheters can be adjusted in length according to the sex of the patient. Catheters for females typically have a urethral length of 3.5cms while the length of a catheter for a male patient can be selected from a typical range of 18 to 20cms after measurement of required urethral length using a calibrated standard balloon catheter.
  • catheters and valves can be manufactured from any material suitable for medical purposes.
  • catheter material is a plastics material.
  • the plastics material is a non-silicon-based material.
  • Catheters can be formed from a single piece of material or comprise tubing sections fitted to the pressure-sensiti e valves. When tubing sections are used, the sections are preferably fused or cemented to the pressure-sensitive valves to secure them thereto.
  • Spiral reinforcement of the catheter can be provided for use in cases where retention is due to narrowing of the urethra from disease, scarring or other external pressure.
  • Spiral reinforcement is typicallv b ⁇ a of a material such as nylon.
  • catheters are typically provided sterile and can be bacteriostatically or bacteriocidally treated, either by impregnation or coating to prevent infection.
  • a plain, sterile catheter can be used with appropriate low dose antibiotic cover.
  • catheters can be fitted into a short introducer external to body which linearises at least the portion of the catheter having shape memory properties. After insertion of the catheter through the introducer the catheter readopts the memorised shape and retains the same in the bladder. Removal of the introducer from around the final section of the catheter can be facilitated by providing a longitudinal split in the introducer.
  • Catheters according to this invention aim at "restoring" a bladder sphincter mechanism allowing the bladder to fill to its usual voiding pressure (30 to 50cms H20) before micturition occurs via opening of the pressure- sensitive valve set at the pressure included in the catheter.
  • the inclusion of a ball and spring valve set at higher pressure level of typically 60 to 70cms water, is intended to overcome stress incontinence. Any sudden increases in intra-abdominal or intra-vesicular pressure will cause compression of the ball and spring device, the ball occluding the narrowed catheter lumen and preventing urine outflow. Steady or slow rises in pressure during normal bladder emptying will be insufficient to compress the "ball and spring" valve.
  • the shape memory feature included in catheters according to the invention permits catheters to be self retained without the need for a double lumen/inflatable intra-vesir l retention balloon.
  • the simplification reduces costs, increases user-friendliness and prevents accidental "urethral stripping" should removal be attempted without fully deflating a balloon.
  • the memorised shape of the intra-vesical part of the catheter can be easily straightened for insertion and removal.
  • Motivated and moderately dexterous patients can be shown how to change their own catheters, but for those less able or willing, medical/paramedical/nursing assistance may be required.
  • Figure 1 depicts a perspective view of a catheter shown in situ with part of the bladder wall in cross- section;
  • Figure 2 depicts a method of inserting a catheter .
  • FIG. 3 shows details of theproposed valves.
  • BEST MODE OF CARRYING OUT THE INVENTION Referring to Figure 1, there is shown catheter 1 having an external urethral meatal end 2 and an lntra- vesicular end 3.
  • the catheter consists of tubing sections 4 and 5 connected to the inlet and outlet respectively of pressure-sensitive valve 6a and ball and spring valve 6b.
  • Tubing section 5 has a bend 7 due to shape memory properties of the plastic which aids retention of the catheter in the bladder.
  • Tubing section 4 also has shape memory properties which cause this intra-vesicular portion to adopt a spiral shape the part of which adjacent valves 6a and 6b further assists retention of the catheter in the bladder.
  • Tubing section 4 which constitutes the bulk of the intra-vesicular portion of the catheter, has a plurality of holes, one of which is indicated at 8.
  • the external urethral meatal end 2 has a ring 9 to assist gripping of the catheter for removal. In situ, the external urethral meatal end 2 of the catheter sits flush with the external body surface 10 of the patient, in this example a female.
  • Catheter section 5 features the soft distensible collar 11 on the external surface of the catheter, with openings for urine inflow on the surface of the collar adjacent to the bladder base. One such opening is indicated at 12.
  • the catheter depicted in the example is made from non-silicon based plastics material.
  • a method of inserting catheters according to the invention is shown in Figure 2.
  • Catheter 21 is supplied with at least the initial part of the portion having shape memory properties within the bore of introducer 22.
  • the introducer is held external to the body with the bore of the introducer adjacent the urethral meatus 23.
  • Catheter 21 is then slowly advanced through the introducer generally in the direction of the arrow.
  • the introducer can be removed when the straighter portion of the catheter, section 5 of the catheter shown in Figure 1, is adjacent urethral meatus 23. This portion of the catheter can be easily advanced into the urethra.
  • the shape memory portion of the catheter reaches the bladder lumen 24, the memorised shape is re- adopted thereby holding the catheter in the bladder.
  • Full aseptic techniques should be used during the insertion of the catheter with or without the introducer.
  • Figure 3 shows the structure of the valves 6(a) 6(b), located in the alternative position in the urethral section 5 of the catheter, distal to bend 7.
  • 6(a) represents a typical pressure-sensiti e inline valve set at 30 to 50cms water pressure, which may be of various designs whilst still complying with the intended principle.
  • 6(b) illustrates the features of the ball and spring valve, having a narrowed intra-lu inal catheter section 13, with intra-luminal spring 14 and attached ball 15.
  • the spring 14 is secured at its base to the walls of the narrowed catheter lumen at 13.
  • the spring 14 is compressible by pressures of or greater than, 60 to 70cms water.
  • the ball component 15 is of such a diameter as to occlude the narrowed lumen 13 of the catheter, when the spring 14 is compressed.
  • the spring 14 is designed to re- assume its relaxed shape when the critical compression pressure ceases.
  • Valve components 13 and 14 may be constructed from a variety of materials suitable for medical use.
  • the present invention is indicated for use in any urinary disorder in eithei male or female, where loss of voluntary contral over micturition has occurred, and where other alternative forms of treatment are awaited, inappropriate or inadequate.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)

Abstract

Un cathéter (1) placé à demeure et ayant un seul lumen résout les problèmes d'incontinence absolue et d'incontinence due au stress. Le dispositif, pré-stérilisé et ayant subi éventuellement un traitement anti-microbien, contient 2 valves (6a et 6b), l'une pré-réglée à une résistance de sortie de la vessie normale (6a), l'autre étant conçue pour supporter des augmentations brusques de la pression intra-abdominale (6b). Le cathéter est automaintenu en raison des propriétés de mémoire de forme spirale dans la partie intra-vésicale (3) qui se caractérise également par plusieurs orifices (8) d'écoulement de l'urine. Les valves se situent au-delà de ces orifices, généralement dans la section urétrale, laquelle se caractérise également par un collier externe dilatable (11) qui constitue un joint d'étanchéité au liquide entre l'urètre et le cathéter. Le cathéter, une fois placé, vient au ras de la surface externe du corps. Il s'enlève facilement grâce à un rebord souple (9), pour un remplacement fréquent.
PCT/AU1995/000429 1994-07-18 1995-07-17 Catheter urinaire WO1996002214A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU29180/95A AU2918095A (en) 1994-07-18 1995-07-17 Urinary catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPM6856A AUPM685694A0 (en) 1994-07-18 1994-07-18 Urinary catheter
AUPM6856 1994-07-18

Publications (1)

Publication Number Publication Date
WO1996002214A1 true WO1996002214A1 (fr) 1996-02-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1995/000429 WO1996002214A1 (fr) 1994-07-18 1995-07-17 Catheter urinaire

Country Status (2)

Country Link
AU (1) AUPM685694A0 (fr)
WO (1) WO1996002214A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0918495A1 (fr) * 1996-08-13 1999-06-02 Galt Laboratories, Inc. Dispositif de maintient de la continence urinaire
WO2001067986A1 (fr) * 2000-03-10 2001-09-20 Conticare Medical, Inc. Dispositif de prevention de l'incontinence urinaire feminine
WO2002011810A1 (fr) * 2000-08-03 2002-02-14 Ranier Limited Cathéter urinaire sans ballonnet
US6464999B1 (en) 1998-06-17 2002-10-15 Galt Incorporated Bioadhesive medical devices
US7329412B2 (en) 2000-12-22 2008-02-12 The Trustees Of Columbia University In The City Of New York Antimicrobial medical devices containing chlorhexidine free base and salt
US8337411B2 (en) 2005-07-14 2012-12-25 C. R. Bard, Inc. Intra-abdominal pressure monitoring system
US8535237B2 (en) 2007-10-23 2013-09-17 C. R. Bard, Inc. Continuous intra-abdominal pressure monitoring system
US20140128666A1 (en) * 2011-04-11 2014-05-08 Floelle Inc. Apparatus and Method for Inhibiting Stress Urinary Incontinence
FR3024651A1 (fr) * 2014-08-11 2016-02-12 Eurl Cornier Dispositif de visualisation de l'uretre feminin en imagerie
US10327880B2 (en) 2000-04-14 2019-06-25 Attenuex Technologies, Inc. Attenuation device for use in an anatomical structure
US10383510B2 (en) 2000-04-14 2019-08-20 Solace Therapeutics, Inc. Implant with high vapor pressure medium
US10531894B2 (en) 2012-08-10 2020-01-14 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US11197981B2 (en) 2019-02-07 2021-12-14 Solace Therapeutics, Inc. Pressure attenuation device
EP4302811A1 (fr) 2022-07-08 2024-01-10 Wellspect AB Ensemble cathéter urinaire et dispositif d'introduction à utiliser dans un tel ensemble
KR20240047032A (ko) * 2022-10-04 2024-04-12 인제대학교 산학협력단 덕빌 타입 복수배액용 배액관 유닛

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3642004A (en) * 1970-01-05 1972-02-15 Life Support Equipment Corp Urethral valve
EP0265207A1 (fr) * 1986-10-20 1988-04-27 Vance Products Incorporated Dispositif trans-urétral pour l'incontinence
GB2219941A (en) * 1988-06-21 1989-12-28 George Herbert Ivan Cornwell Urinary incontinence control device
US4932938A (en) * 1989-05-05 1990-06-12 Medical Engineering Corporation Urethral indwelling catheter with incontinence control
US4946449A (en) * 1986-12-18 1990-08-07 Davis Jr Richard C Indwelling urethral catheter system and method
EP0407218A1 (fr) * 1989-07-07 1991-01-09 Cabot Technology Corporation Dispositif pour contrôler l'incontinence féminine
GB2235383A (en) * 1989-08-29 1991-03-06 Bristol Myers Squibb Co Urethral indwelling catheter with magnetically controlled drainage valve
US5140999A (en) * 1991-09-30 1992-08-25 Primed International Corp. Urinary incontinence valve device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3642004A (en) * 1970-01-05 1972-02-15 Life Support Equipment Corp Urethral valve
EP0265207A1 (fr) * 1986-10-20 1988-04-27 Vance Products Incorporated Dispositif trans-urétral pour l'incontinence
US4946449A (en) * 1986-12-18 1990-08-07 Davis Jr Richard C Indwelling urethral catheter system and method
GB2219941A (en) * 1988-06-21 1989-12-28 George Herbert Ivan Cornwell Urinary incontinence control device
GB2219943A (en) * 1988-06-21 1989-12-28 George Herbert Ivan Cornwell Urinary incontinence control device
US4932938A (en) * 1989-05-05 1990-06-12 Medical Engineering Corporation Urethral indwelling catheter with incontinence control
EP0407218A1 (fr) * 1989-07-07 1991-01-09 Cabot Technology Corporation Dispositif pour contrôler l'incontinence féminine
GB2235383A (en) * 1989-08-29 1991-03-06 Bristol Myers Squibb Co Urethral indwelling catheter with magnetically controlled drainage valve
US5140999A (en) * 1991-09-30 1992-08-25 Primed International Corp. Urinary incontinence valve device

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0918495A4 (fr) * 1996-08-13 2002-03-06 Galt Lab Inc Dispositif de maintient de la continence urinaire
EP0918495A1 (fr) * 1996-08-13 1999-06-02 Galt Laboratories, Inc. Dispositif de maintient de la continence urinaire
US6464999B1 (en) 1998-06-17 2002-10-15 Galt Incorporated Bioadhesive medical devices
WO2001067986A1 (fr) * 2000-03-10 2001-09-20 Conticare Medical, Inc. Dispositif de prevention de l'incontinence urinaire feminine
US10327880B2 (en) 2000-04-14 2019-06-25 Attenuex Technologies, Inc. Attenuation device for use in an anatomical structure
US10383510B2 (en) 2000-04-14 2019-08-20 Solace Therapeutics, Inc. Implant with high vapor pressure medium
WO2002011810A1 (fr) * 2000-08-03 2002-02-14 Ranier Limited Cathéter urinaire sans ballonnet
US7329412B2 (en) 2000-12-22 2008-02-12 The Trustees Of Columbia University In The City Of New York Antimicrobial medical devices containing chlorhexidine free base and salt
US8337411B2 (en) 2005-07-14 2012-12-25 C. R. Bard, Inc. Intra-abdominal pressure monitoring system
US8535237B2 (en) 2007-10-23 2013-09-17 C. R. Bard, Inc. Continuous intra-abdominal pressure monitoring system
US20140128666A1 (en) * 2011-04-11 2014-05-08 Floelle Inc. Apparatus and Method for Inhibiting Stress Urinary Incontinence
US9510924B2 (en) * 2011-04-11 2016-12-06 Floelle Inc. Apparatus and method for inhibiting stress urinary incontinence
US10543071B2 (en) 2012-08-10 2020-01-28 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US10531894B2 (en) 2012-08-10 2020-01-14 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US10799268B2 (en) 2012-08-10 2020-10-13 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
EP2984990A1 (fr) * 2014-08-11 2016-02-17 Eurl Cornier Dispositif de visualisation de l'angle de clôture médio urétral de l'urètre de l'urètre féminin à l'aide de imagerie par résonance magnétique nucléaire ou par échographie
FR3024651A1 (fr) * 2014-08-11 2016-02-12 Eurl Cornier Dispositif de visualisation de l'uretre feminin en imagerie
US11197981B2 (en) 2019-02-07 2021-12-14 Solace Therapeutics, Inc. Pressure attenuation device
EP4302811A1 (fr) 2022-07-08 2024-01-10 Wellspect AB Ensemble cathéter urinaire et dispositif d'introduction à utiliser dans un tel ensemble
WO2024008537A1 (fr) 2022-07-08 2024-01-11 Wellspect Ab Ensemble cathéter urinaire et dispositif introducteur destiné à être utilisé dans un tel ensemble
KR20240047032A (ko) * 2022-10-04 2024-04-12 인제대학교 산학협력단 덕빌 타입 복수배액용 배액관 유닛
KR102780978B1 (ko) * 2022-10-04 2025-03-17 인제대학교 산학협력단 덕빌 타입 복수배액용 배액관 유닛

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